MAUDE Adverse Event Report: NORMAND-INFO S.A.S.U. REMISOL ADVANCE (RADV); CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number SERVER, DELL T310, WIN 2008 OS, REMISOL ADVANCE

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

The customer stated that the issue occurred since one supervisor incorrectly activated new progesterone rules setting in remisol advance (radv).Beckman coulter cts (customer technical support/holtine) reviewed patient data and confirmed the incorrect setting.The customer deactivated the erroneous progesterone rules to resolve the issue.Age/date of birth, weight, and ethnicity: information not provided by the customer.Reporting contact telephone number is (b)(6).The beckman coulter internal identifier is case (b)(4).

Event Description

The customer reported that the remisol advance (radv lis: laboratory information system) released false low progesterone results for five (5) pregnant patient samples.The results were released from the laboratory.There was no report of injury or death; no change in patient treatment in association with this event.Two (2) patients were prescribed to take more progesterone to their daily dosage.The results were amended and the two (2) patients were advised to lower their doses.There was no report of impact on patient's treatment or patient's health for the other three (3) patients.

• Brand Name: REMISOL ADVANCE (RADV)
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras pas-de-calais 62028 ; FR 62028
• Manufacturer (Section G): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras pas-de-calais 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2 ieme etage; arras 62000 ; FR 62000
• MDR Report Key: 11499664
• MDR Text Key: 253057291
• Report Number: 3006543086-2021-00001
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Public: (01)NOT-FOUND(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SERVER, DELL T310, WIN 2008 OS, REMISOL ADVANCE
• Device Catalogue Number: B07566
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/04/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other